Device for administering a fluid product

ABSTRACT

An administering device for a fluid product includes a product receptacle that accommodates the product to be administered, a fluid reservoir for a driving fluid, a driving means, a product chamber, and a fluid connection. The product receptacle includes an opening at a forward end and a product stopper at a rear end. The driving means acts upon the fluid reservoir, the pressure chamber adjoins the product stopper while the fluid connection is located between the fluid reservoir and the pressure chamber, and the driving means acts upon the fluid reservoir in such a way that the pressure chamber is impinged upon by pressure which affects the product stopper and the product is discharged from the product receptacle.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Ser. No. 11/923,339 filedOct. 24, 2007, issued on Sep. 7, 2010 as U.S. Pat. No. 7,789,858, whichis a continuation of International Application No. PCT/CH2006/000221,filed 24 Apr. 2006, which claims the benefit of priority from SwissApplication No. 724/05, filed 25 Apr. 2005, the subject matter of bothare hereby incorporated by reference in their entirety.

BACKGROUND

The present invention relates to devices for injecting, infusing,administering, delivering or dispensing substances, and to methods ofmaking and using such devices. More particularly, the invention relatesto a device for administering a fluid product, in particular a devicefor administering a fluid product at a continuous delivery rate.

For various diseases, such as for example diabetes, it can be necessaryto continuously administer a particular amount of a fluid medicine to apatient. Various systems for this purpose are known, which enable themedicine to be supplied continuously over an extended period of time.The period of time of administration, the amount of the productadministered within the period of time, the repetition rate of a numberof consecutive administrations and possible extra deliveries can usuallybe set in such systems. Administering devices are known which can beconnected to an external product container for a fluid medicine and, assoon as said container is empty, can be connected to the next container.Accordingly, such administering systems can be reused. Furthermore,implantable devices are also known which can be inserted into apatient's body tissue and are coupled to an external product containerby means of a connector. Various possibilities exist for driving suchsystems, such as for example using gravity, various drive systems in theform of mechanical springs or hydraulic drives. In order to regulate theflow rate, the flow amount from the product container for the fluidmedicine is usually limited at the outlet. Simple valves, clamps orprogrammable electronic devices can be used for this.

U.S. Pat. No. 5,788,673 discloses an infusion system in which a driveunit is combined with a conventional syringe. The syringe includes aproduct container that accommodates the fluid product, and a drivepiston rod by which a product stopper within the product container canbe advanced. The fluid product can be discharged from the syringethrough an outlet opposite the product stopper. At the opening, thesyringe also includes a valve for regulating the fluid flow. The driveunit comprises a chamber for a liquid medium, a second chamber whichcommunicates with the first chamber, a piston and a valve system. Aspring force can be exerted on the piston that conveys the liquid mediumfrom the first chamber to the second chamber and back. The valve systemcontrols the movement of the piston in the forward or backward directionand thus the discharge of the fluid product from the syringe.

The known systems for administering fluid medicines are generallydesigned to be reused. They therefore exhibit a complex constructioncomprising a large number of components and are therefore costly tomanufacture. Furthermore, the patient or an assistant has to learn howto change the administering device from an empty product container to anew, full product container. If handled incorrectly, it is for examplepossible for an incorrect dosage to be administered to a patient.

SUMMARY

The present invention to provides a device for administering a fluidmedicine, which is easy to handle, can be initiated in a few operatingsteps, ensures reliable functioning and ensures a continuous dischargeat a constant medicine rate.

In addition, according to the invention, an administering device forcontinuously administering a fluid medicine, which is suitable for beingused once, is provided.

The administering device of the present invention, according to certainembodiments, is configured to administer a fluid product, primarily atherapeutic medicine such as for example insulin. However, theadministering device may also be used for administering other fluidproducts, which are to be administered into a body tissue. Theadministering device comprises a product container which accommodatesthe product to be administered and comprises an opening for dischargingthe product from the product container at its front, distal end, and aproduct stopper at its rear, proximal end. A typical ampoule, such as isused for injection syringes or pens for quickly administering smalldosages and/or injection shots, may be used as the product container.The product stopper may be moved relative to the product container andseals the proximal end of the container in a fluid-proof seal.

According to various embodiments, the administering device alsocomprises a fluid reservoir for a drive fluid and a drive means thatacts on the fluid reservoir. The drive fluid may be a non-compressibleliquid. At least one of the fluid reservoir and the product containershould be a non-compressible chamber; and in some implementations, thefluid reservoir and the product container are each formed by anon-compressible chamber. A non-compressible chamber may include solid,stable walls in a suitable geometric shape. The fluid reservoir includesa drive stopper, which transfers the action of the drive means onto thedrive fluid within the fluid reservoir and charges the fluid reservoirwith pressure. Various systems, including known systems, can be used asthe drive means, such as for example mechanical springs, hydraulicdrives or gas drives. A mechanical spring, for example a mechanicalpressure spring, may be used as the drive means in the presentinvention.

A pressure chamber may be connected to the product stopper of theproduct container, according to some implementations. The pressurechamber may be formed by one or more walls of the product container, theproduct stopper and a closed end of the'container. The closed end of thepressure chamber may be formed by a casing wall, such as by means of aseal. Accordingly, the pressure chamber may be at least partially orcompletely arranged within the product container. According to certainembodiments, the product container may be subdivided by the productstopper into a chamber for the product and the pressure chamber. A fluidconnection is provided between the fluid reservoir and the pressurechamber, and the drive fluid may be conveyed out of the fluid reservoir,through the fluid connection, into the pressure chamber.

In accordance with the present invention, the drive means acts on thefluid reservoir in such a way that the pressure chamber is charged withpressure via the fluid connection, said pressure acting on the productstopper and thus discharging the product from the product container.Although for certain embodiments, a casing of the device forms acompartment for a product container, which is or can be accommodated init, the casing, in other embodiments, may accommodate one or more or allof the components of the administering device in order to directly formthe product container.

According to one embodiment of the present invention, the fluidconnection exhibits a first, resting state in which it is closed, i.e.in which no drive fluid can flow from the fluid reservoir to thepressure chamber. A connecting means is provided in the administeringdevice and moves the fluid connection from the first, closed, restingstate to a second, open, administering state in which the fluidconnection is open to the drive fluid. The connecting means thereforeserves to connect the fluid reservoir containing the drive fluid to thepressure chamber connected to the product stopper of the productcontainer. If, in the second, open state, the drive means then acts onthe fluid reservoir or drive stopper of the fluid reservoir, the drivefluid is conveyed through the fluid connection.

According to certain embodiments, the drive means is biased in theadministering device in the resting state; i.e. the drive meansconstantly acts on the fluid reservoir or drive stopper. The drive meansmay be held in the biased position by a holding and/or securing device.The holding device may include known locking systems in which, forexample, the drive stopper of the drive means is held in place by amovable latch or stopper, for example, which may be removed or releasedby a push button or slider in order to release the locking system. Inanother embodiment, the holding device may be formed by the seal of thefluid connection, for example by means of the sealing membrane. The biason the drive means may then be released by opening the fluid connection.In alternative embodiments, the drive means may only be tensed when thefluid connection is opened or after the fluid connection has beenopened.

According to one embodiment, a casing is provided which accommodates theproduct container, the fluid reservoir, the pressure chamber and thefluid connection. In some implementations, a pre-assembled unit may beprovided that includes the casing, the fluid reservoir, the pressurechamber and the fluid connection, and comprises a compartment into whichthe product container can be inserted when necessary, for exampleshortly before the required administration. Accordingly, in order to usethe administering device in accordance with the invention, only theproduct container need be inserted into the casing compartment. When theproduct container is inserted into the casing, the connecting means maybe activated, such that the fluid connection is moved from the restingstate to the administrating state. If the drive means is already biasedwithin the casing, the drive means may be triggered with the aid of theproduct container and the pressure chamber consequently charged withpressure. The pressure force begins to act on the drive stopper in sucha way that the stopper is shifted relative to the fluid reservoir, anddrive fluid flows from the fluid reservoir into the pressure chamber,wherein a pressure is built up in the pressure chamber which acts on theproduct stopper, and the fluid product is therefore discharged throughthe opening in the product container.

According to certain embodiments, the fluid connection comprises asealing membrane for sealing it. The fluid connection may be moved fromthe closed state to the open state by penetrating the sealing membrane,and connecting means then exhibits a flow cross-section through whichproduct can flow. For example, a tube-like hollow element, such as ahollow needle, conduit, capillary, or passage may serve as a connectingmeans and penetrate and/or pierce the sealing membrane of the fluidconnection. Accordingly, the connecting means can form a part of thefluid connection. It is for example possible on the one hand for thefluid connection to be formed by a narrow capillary which feeds from thefluid reservoir, is conveyed within the casing towards the productcontainer compartment, and is sealed with the sealing membrane at theend, which feeds into the compartment, and on the other for the fluidconnection to be formed from the hollow needle of the connectingelement. The pressure in the pressure chamber may be defined bydimensioning the fluid connection. The pressure in the pressure chamberis dependent on the size of the outlet area and/or the diameter of thefluid connection and on the length of the capillary. It is independentof the pressure of the drive element on the fluid reservoir or drivestopper. This implementation enables pressure fluctuations in the drivemeans to be equalized. In some implementations, the fluid connection mayhave a diameter of about 0.5 to about 3 mm. It is also possible toarrange the fluid connection within the casing in a looping, spiralling,meandering or labyrinthine manner. This enables the fluid connectionpath between the fluid space and the pressure chamber to be lengthenedand the pressure in the pressure chamber to be regulated by selecting aparticular fluid connection length.

In a particular embodiment, the connecting means forms a partial sectionof the fluid connection in the state in which the fluid reservoir isconnected to the product reservoir. In another embodiment, theconnecting means alone forms the fluid connection in the connectedstate. Alternatively, the hollow element, which penetrates the sealingmembrane, may form the fluid connection. For example, the sealingmembrane may form a wall of the fluid reservoir thus allowing the hollowelement to form a fluid connection with the fluid in the reservoir oncethe hollow element penetrates the membrane.

The administering device of the present invention may be configured tobe a single-use device. A user inserts the product container into thecasing comprising the other components of the device, which in someembodiments, connects the pressure chamber to the fluid reservoir.Inserting may also simultaneously trigger administration. No furtherhand operations are necessary in order to initiate the device orregulate the administering amount. Once administration is complete, i.e.as soon as the product container is empty, the connection to the patientcan be interrupted and the whole administering apparatus disposed of.

In alternative embodiments, the administering device may be reusable.If, for example, the drive means is only tensed or charged when theproduct container is inserted or after the product container has beeninserted or by inserting the product container, the administering devicemay be repeatedly charged and used by again inserting a productcontainer. The drive means can also be biased before a new productcontainer is inserted.

According to some implementations, the connecting means is activated bythe product stopper when the product container is inserted into thecasing. As described, this can move the fluid connection from a closedstate to an open state. It is, however, also simultaneously possible toform the connecting means in such a way that the product stopper withinthe product container is shifted in the distal direction of the productcontainer when the container is inserted into the casing. The connectingmeans may advance the product stopper by a distance which allows theproduct container to be vented. This only requires a small movement bythe product stopper within the product container, which may removepossible air pockets within the product container through the frontopening of the product container, and the administering device may bedirectly connected to an administering conduit, which leads to thepatient. The frictional force to overcome the snug fit of the productstopper in the product container is preferably greater than the forcerequired to move the fluid connection from the closed state to the openstate, i.e. to pierce the sealing membrane. When the product containeris inserted, the membrane is then pierced first and the fluid connectionbetween the fluid reservoir and the pressure chamber thus opened, andthen the product stopper is distally shifted by a venting distance. Thepressure building up in the pressure chamber immediately begins toadvance the product stopper and thus administer the product.

In accordance with another aspect of the invention, a method is claimed,according to which, in a device for administering, and in someinstances, for continuously administering, a fluid product, inserting aproduct container triggers the administration and/or a venting processfor venting a product container.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a first embodiment of an administering apparatus inaccordance with the present invention, in a resting state;

FIG. 2 depicts the administering device according to FIG. 1, in anadministering state;

FIG. 3 depicts the administering device during administration; and

FIG. 4 depicts a second embodiment of an administering device inaccordance with the present invention.

DETAILED DESCRIPTION

FIG. 1 shows a first embodiment of an administering device in accordancewith the present invention. The administering device comprises a casing(1) in which a product container in the form of an ampoule (2), a fluidreservoir (3), a drive means in the form of a spring (4), a fluidconnection (5) and a connecting means (6) are accommodated. Water may beused as the drive fluid, the physical parameters of which are wellknown. However, it is also possible to use other fluids that differ inviscosity. The ampoule (2) is filled with the fluid product (7). Ampoule(2) comprises an opening (8) at its front, distal end and a productstopper (9) at its rear, proximal end. In FIG. 1, the ampoule (2) hasnot yet been completely inserted into the casing (1) and theadministering device is in its resting state.

In the embodiment in accordance with FIGS. 1 to 3, the ampoule (2) andthe fluid reservoir (3) together with the spring (4) are arranged nextto each other, offset in parallel, within the casing. The fluidconnection (5) forms a transverse connection within the casing (1). Thisarrangement enables the overall length of the administering device to bekept small. The fluid connection (5) is spread over the area of thecasing (1) in a number of loops (not shown).

The connecting means (6) is provided within the casing (1) as a movableelement. The connecting means (6) can be moved along the longitudinalaxis of the ampoule and is arranged between the ampoule (2) and thefluid connection (5) and comprises a hollow needle (10). The fluidconnection (5) is permanently connected to the fluid reservoir (3) atone end and sealed by a sealing membrane (13) at the other end. Thehollow needle (10) of the connecting element (6) is arranged oppositethe sealing membrane (13) at an axially small distance. In addition, theconnecting means (6) is provided centrally relative to the productstopper (9).

The system consisting of the spring (4), the fluid reservoir (3), thefluid connection (5) and the sealing membrane (13) forms a sealed fluidsystem in the resting state. In this embodiment, the spring (4) isalready biased within the system. Even in the resting state, ittherefore exerts a pressure on the fluid reservoir comprising the drivefluid. The sealing membrane (13) is therefore embodied such that itwithstands this pressure.

In FIG. 2, the ampoule (2) has been completely inserted into the casing(1) of the administering device. When the ampoule (2) is completelyinserted into the casing (1), the product stopper (9) comes to rest onthe connecting means (6). If the ampoule (2) is inserted further, theproduct stopper (9) initially presses the connecting element (6) towardsthe sealing membrane (13) until the hollow needle (10) pierces themembrane and the connecting element (6) abuts a shift stopper (14),which may be formed by the casing or may be affixed to the casing. Theconnecting means (6) cannot then be shifted further in the direction ofthe longitudinal axis of the ampoule, relative to the casing. Theampoule (2) can, however, still be inserted further in the insertiondirection, into the casing (1), wherein the product stopper (9), whichabuts the connecting means (6), is shifted relative to the wall of theampoule (2). This shift path of the product stopper (9) reduces thevolume within the ampoule (2) for the fluid product, and the ampoule isvented and/or a small amount of the fluid product is discharged from theampoule (2) through the opening (8). A small shift path of a fewmillimetres is sufficient for the venting process. The ampoule (2) isinserted into the casing (1) until it also abuts a shift stopper (14)within the casing, wherein the circumference of the proximal end of theampoule (2) abuts a seal (11). In order to secure the ampoule (2) withinthe casing (1), a latching or locking mechanism can advantageously beprovided.

The administering device is then in an administering state in which afluid connection (5) is provided by piercing the sealing membrane (13)in the open state.

FIG. 3 shows the administering device in the administering state, aftera certain product amount has been administered. The pressure chamber(12), which is formed by the wall of the ampoule (2), the productstopper (9), the connecting means (6) and the seal (11), can be seen inFIG. 3. Since the spring (4) is mounted, already biased, within thecasing, opening the fluid connection (5) causes the drive fluid to flowfrom the fluid reservoir (3), through the fluid connection (5) throughthe hollow needle (10), into the pressure chamber (12). The flow amountthrough the fluid connection (5) depends on the diameter and length ofthe fluid connection (5). The pressure exerted on the product stopper(9) is therefore independent of variants in the pressure of the driveelement, i.e. the spring (4). The discharge rate of the administeringdevice can be defined by selecting the diameter and length of the fluidconnection (5) and then remains constant throughout the administrationof the fluid product (7) from the ampoule (2).

As soon as the product stopper (9) has reached the front, distal end ofthe ampoule (2), the ampoule is completely empty and the administeringdevice can be disposed of.

FIG. 4 shows another embodiment of the present invention, in which theampoule (2), the fluid reservoir (3) and the drive spring (4) arearranged along the same axis within the casing (1). In this embodiment,the administering device exhibits a slim, elongated shape. Its mode ofoperation corresponds to the functioning of the embodiment from FIGS. 1to 3.

In this second example embodiment, the connecting means (6), i.e. itshollow needle (10), alone forms the entire fluid connection (5) betweenthe fluid reservoir (3) and the pressure chamber on the proximal side ofthe product stopper (9).

Embodiments of the present invention, including preferred embodiments,have been presented for the purpose of illustration and description.They are not intended to be exhaustive or to limit the invention to theprecise forms and steps disclosed. The embodiments were chosen anddescribed to provide the best illustration of the principles of theinvention and the practical application thereof, and to enable one ofordinary skill in the art to utilize the invention in variousembodiments and with various modifications as are suited to theparticular use contemplated. All such modifications and variations arewithin the scope of the invention as determined by the appended claimswhen interpreted in accordance with the breadth they are fairly,legally, and equitably entitled.

1. A device for administering a fluid product, comprising: a productcontainer having two ends and configured to accommodate the fluidproduct to be administered, said product container comprising an openingat one end and a product stopper movable relative to the productcontainer at the other end; a fluid reservoir for accommodating a drivefluid; a drive member operatively coupled to the fluid reservoir; apressure chamber operatively coupled to the product stopper; and aconnecting means for forming a fluid connection between the fluidreservoir and the pressure chamber, said connecting means comprising afirst state and a second state, wherein the fluid connection is closedin the first state and is open in the second state such that the fluidconnection is open to the drive fluid; wherein, when the productcontainer is inserted into the device, the connecting means is activatedsuch that the fluid connection is moved to the second state, andwherein, in the second state, the drive member acts on the fluidreservoir such that the pressure chamber is charged with a pressure thatacts on the product stopper and the product is discharged from theproduct container.
 2. The administering device according to claim 1,further comprising: a seal for sealing the fluid connection when theconnecting means is in the first state; and upon activating theconnecting means, the connecting means pierces the seal as theconnecting means moves from the first state to the second state.
 3. Theadministering device according to claim 2, wherein upon the connectingmeans piercing the seal, the product stopper is shifted by a ventingdistance.
 4. The administering device according to claim 1, wherein theconnecting means comprises a tube-like hollow element and, when theconnecting means is activated, the tube-like hollow element fluidlyconnects the fluid reservoir and pressure chamber.
 5. The administeringdevice according to claim 4, wherein the tube-like hollow element has aflow section which exhibits a maximum flow resistance.
 6. Theadministering device according to claim 1, wherein the pressure in thepressure chamber is set by dimensioning the fluid connection.
 7. Theadministering device according to claim 1, wherein the connecting meanscomprises a tube-like hollow element forming at least a portion of thefluid connection.
 8. The administering device according to claim 1,wherein when the product container is inserted into the device theconnecting means is activated by the product stopper.
 9. Theadministering device according to claim 8, wherein the connecting meanscomprises a bearing structure between the product stopper and the fluidconnection and movable along a longitudinal axis of the productcontainer, wherein the product stopper moves the bearing structuretoward the fluid connection to activate the connecting means.
 10. Theadministering device according to claim 9, wherein the bearing structureabuts a shift stopper as the bearing structure moves toward the fluidconnection, which shift stopper stops movement of the bearing structureand, as the product container is inserted further into the device, thebearing structure abuts the product stopper such that the productstopper shifts to reduce a volume of the product container.
 11. Theadministering device according to claim 10, wherein the productcontainer ceases an insertion movement as a proximal end of the productcontainer abuts a seal within the device.
 12. The administering deviceaccording to claim 1, wherein the pressure chamber is formed by theproduct container, the product stopper and the connecting means.
 13. Theadministering device according to claim 12, wherein the device comprisesa product container seal that abuts a proximal end of the productcontainer when the pressure chamber is formed.
 14. The administeringdevice according to claim 13, wherein the product container is securedto the device by a latching or a locking mechanism.
 15. Theadministering device according to claim 1, wherein: the device forms acompartment comprising an opening; and the product container can beinserted into the compartment through the opening; wherein inserting theproduct container opens the fluid connection which is sealed before theproduct container is inserted.
 16. A device for administering a fluidproduct, comprising: a product container having two ends and configuredto accommodate the fluid product, the product container insertable intothe device and comprising an opening at one end and a moveable productstopper adjacent to the other end; a fluid reservoir for accommodating adrive fluid; a drive member operatively coupled to the fluid reservoir;a pressure chamber operatively coupled to the product stopper; and afluid connection between the fluid reservoir and the pressure chamberand having a first state and a second state, wherein the fluidconnection is closed in the first state and open in the second state;wherein, when the product container is in the device, the fluidconnection is in the second state and the drive member acts on the fluidreservoir whereby the pressure chamber is charged with a pressure thatacts on the product stopper and product is discharged from the productcontainer.
 17. The device according to claim 16, further comprising aseal in the fluid connection, the seal being pierced in the secondstate.
 18. The device according to claim 17, further comprising abearing structure moveable to contact the product stopper.
 19. Thedevice according to claims 18, wherein the pressure chamber is formed bya portion of the product container, the product stopper, the seal and aportion of the fluid connection.
 20. A method for continuouslyadministering a fluid product, using an administering device, the methodcomprising the steps of: providing an administering device comprising: aproduct container configured to accommodate the fluid product to beadministered, said product container comprising an opening at a frontend and a product stopper movable relative to the product container at arear end; a fluid reservoir for accommodating a drive fluid; a driveelement operatively coupled to the fluid reservoir; a pressure chamberoperatively coupled to the product stopper; and a fluid connectionbetween the fluid reservoir and the pressure chamber, said fluidconnection comprising first state and a second state, wherein the fluidconnection is closed in the first state is opened in the second statesuch that the fluid connection is open to the drive fluid; and actuatingthe administering device by inserting the product container into thedevice such that the fluid connection is activated and moved to thesecond state, wherein, in the second state, the drive element acts onthe fluid reservoir such that the pressure chamber is charged with apressure which acts on the product stopper to move the product stopperby a venting distance.
 21. The method according to claim 20, furthercomprising administering the product from the product container aftermoving the product stopper by the venting distance.
 22. The methodaccording to claim 20, further comprising biasing the drive element uponinserting the product container into the device.
 23. The methodaccording to claim 20, further comprising biasing the drive elementbefore inserting the product container into the device.
 24. The methodaccording to claim 23, wherein the device further comprises a sealingmembrane, which closes the fluid connection in the first state andwithstands a pressure exerted on it by way of the biased drive element.